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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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New Enrollment PAS


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General
Study Status Study Pending
Application Number P170043 / PAS002
Date Current Protocol Accepted  
Study Name New Enrollment PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description To evaluate the rate of clinically relevant complication associated with iStent inject® placement and stability, as determined at 36 months in the postmarket setting compared to the pre-specified performance target of 2%. This is a prospective, non-randomized, multicenter, single arm, post approval study of the iStent inject®. This is a new enrollment study, in which the subject enrollment phase to qualify and treat 358 eyes of 358 subjects at up to 30 sites is expected to last up to 37.5 months and include 10 study visits.
Study Population Description Adults who must have mild to moderate open angle glaucoma (OAG) in the study eye and also be undergoing cataract surgery in that eye. No comparator group.

Inclusion criteria:

1. Adults, 22 years of age or older at the time of surgery.

2. Able to understand the requirement of the study and willing to follow study instructions, provide written consent, and agree to comply with all study requirements, including the required study follow-up visits

3. Diagnosis of mild to moderate open angle glaucoma with C/D ratio less than or equal to 0.8, and characteristics consistent with mild to moderate glaucoma, defined as visual field defects (with mean deviation not worse than -12dB), OR nerve abnormally characteristic of glaucoma

4. Medicated intraocular pressure (IOP) less than or equal to 24 mmHg, or an unmedicated IOP of greater than or equal to mmHg and less than or equal to 36 mmHg.

5. Gonioscopy confirming normal open angle in the designated study eye as defined by Shaffer grade greater than or equal to 3, and absence of peripheral anterior synechia (PAS), rubeosis or other angle abnormalities that could impair proper placement of stent.

6. An operable age-related cataract with best spectable corrected visual acuity (BSCVA) of 0.3 logMAR or worse (less than or equal to 70 letters read), eligible for phacoemulsification, if the BSCVA is better than 0.3 logMAR (> 70 letters read), testing with a Brightness Acuity Meter (MAT) on a medium setting must result in a BSCVA of 0.3 logMAR or worse (less than or equal to 70 letters read)

7. An intact and centered capsulothexis or capsulotomy

8. An intact posterior capsular bag

9. A well-centered IOL implant placed in the capsular bag

10. A clear view of an open angle and visualization of the angle with direct gonioscopy post intracameral miotic instillation

11. No evidence of zonular dehiscence/rupture (uncomplicated cataract extraction)

Exclusion criteria:

1. Eyes with angle closure glaucoma

2. Eyes with traumatic, malignant, uveitic, or neovascular glaucoma or discernible congential anomalies of the anterior chamber (AC) angle

3. Patients with retrobulbar tumor, thyroid eye disease, Sturge-Weber Syndrome or any other type of condition that may cause elevated episcleral venous pressure
Sample Size The sample size calculation is based on the statistical hypotheses below suggested by ISO 11979-7 for safety events:

H0: p less than or equal to 0.02 versus Ha: p > 0.02, where p = the probability of having clinically relevant complications associated with iStent inject placement and stability during the 36-month follow-up period. A one-sided significance level of 0.05 is used.

Based on the binomial distribution, a sample size of 250 eyes can provide a statistical power of 80% at a true p of 0.05. Considering a drop-out rate of 30% at 36 months for this post-approval study, the study should treat at least 358 eyes of 358 subjects.

Data Collection Safety Endpoint: The rate of clinically relevant complications associated with iStent inject placement and stability as determined at 36 months. Specific device-related complications include clinical sequelae resulting from device position including, but not limited to:

Secondary surgical intervention (SSI) to modify device position (e.g., repositioning or explantation)

Corneal endothelial touch by device

Corneal edema leading to BSCVA loss > 2 lines at the Month 36 visit, in comparison with preoperative BSCVA



Other Safety Outcomes:

Rate of occurrence of sight-threatening adverse events including:

Persistent (at time of study exit) BSCVA loss greater than or equal to 3 lines compared to best recorded BSCVA at any postoperative visit

Endophthalmitis

Corneal decompensation

Retinal detachment

Severe choroidal hemorrhage or detachment or aqueous misdirection

Rate of ocular secondary surgical interventions (SSI)



Rate of other adverse events including:

Increase from baseline IOP of greater than or equal to 10 mmHg at any time greater than or equal to 30 days postoperative

BSCVA loss greater than or equal to 2 lines at Month 36 compared to screening

BSCVA loss greater than or equal to 2 lines at Month 36 compared to best recorded BSCVA at any postoperative visit

Device movement, defined as a stent not visible in the original location, that does not result in clinically relevant complications as described above (e.g., SSI to modify device position, corneal endothelial touch by device, or corneal edema leading to BSCVA loss > 2 lines at the Month 36 visit compared to preoperative BSCVA), and that is not attributable to any one or more of the following:

variations in gonioscopic, OCT or UBM viewing angle or illumination

changes in angle anatomy due to concomitant findings such as resolution of hyphema

changes in anterior chamber depth

development of focal peripheral anterior synechiae (PAS)



Follow-up Visits and Length of Follow-up 36 months


New Enrollment PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 12/20/2018 01/15/2019 Overdue/Received
one year report 06/21/2019 06/14/2019 On Time
18 month report 12/20/2019    
two year report 06/20/2020    
three year report 06/20/2021    
four year report 06/20/2022    


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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